Medical 21 | Manny Villafaña, CEO


Manny Villafaña, PhD, Sc

Manny Villafaña, PhD, Sc

Founder of St. Jude Medical, ATS, Cardiac Pacemakers, Currently CEO of Medical 21
Read Biography
Developing an artificial artery to eliminate the harvesting of vessels from the patient during bypass CABG surgery.


Manny Villafana  0:02  

We got a deal. I said that only nine minutes. And if I go a little bit over, he says, Don't worry, man, you got a big clock, I'll just pull you off here, I have to apologize that I have to go through the slides quite rapidly. But nine minutes is nine minutes. To give you an idea of who I may be, if you haven't been around the meeting last night, I've done this before, been the CO developer of the first lithium powered pacemakers, and then develop the St. Jude heart valve, which was bought out by Abbott for $30 billion. Ben, also the CO inventor of the ATS heart valve, which was later on bought out by by Medtronic. But the work that we're going to be talking to you about is something that we began around 2014 When we were working on a project called kips Bay medical in which we were taking vessels and strengthening them with nitinol wire before putting them on the heart that was going quite well, except a little thing called the Great Recession came in and interfered with that. So we revisited how we were going to do that. Instead, we decided, why not make an artificial graph. Okay. Now, of course, a lot of people said, man, you're crazy. But then I said, Well, you know, we've done this before. We we've had the experience, and so we decided to go after it. And the reason very simply is that heart disease is still the number one cause of death. It's not the COVID it's not cancer, but still heart disease is our number one killer. Now, typical patient comes in, goes to the doctor, I got chest pain, what are we going to do about this? Doctor will look at and do a do an angioplasty, not angioplasty but an angiogram and we'll say, Charlie, you got some blockages, okay, we're going to take take care of them by trying to open up those blockages with a standard balloon, which we will attach a stent that will not only open up that blockage, that lesion, but we will leave behind a stent that will help keep it open. Ci doc, that works. I don't feel any pain anymore. Okay, go home, Charley. All right. However, in a relatively short period of time, maybe two or three years. In some cases, some cases maybe in a couple of weeks. Daca got that pain again? Well, let's take a look. Well, it turns out that again, you have a situation where you have develop other blockages. The the stent that we put in side of you is totally occluded. So we're going to have to go and do a bypass on you. Meaning that we're going to try to take vessels out of your body and connect them in such a way so that we can go around those blockages and we are going to do bypass surgery on you. Now the image that we see in front of us right now, is what I would call a double bypass, in which you have a lesion in the right coronary and also a lesion on the LED. However, to do that, we have to harvest vessels from your body. And the typical method that we use primarily outside the US but still also in the US as well is that we will have to fillet your leg for lack of a better word, open up your leg as you can see there and pull out the saphenous vein. And in 23% of the patients, we still need more vessels, so we'll open up your arm as well to pull out the radial arteries. endoscopic harvesting has helped in reducing some of this trauma on the legs and on the arms, but still require a situation where you have a very highly trained technician that has to use about $1,500 worth of disposable to open up the legs and the arms to try to pull out these vessels cauterize them etc. And unfortunately, this procedure is not well accepted because it really does a lot of damage, but it is what it is. And this is what we have to work with these days. Now, how big of a market this is this will typically bypass surgery is in 800,000 to a million patients per year on a worldwide basis. And the average patient received between three and four graphs typically, triple quadruple bypass whatever you want to call it, which means basically three and a half graph, not that you walk around with a half a graph I O We'd have to say it's an average, okay, which means the market is somewhere between two and a half and three and a half million grafts done annually. And so our concept is simple. Why can't we develop an artificial artery, a small diameter graph for cabbage, okay? Sure, it's gonna have to be thin, flexible, compliant, strong, etc, and things like that. Okay. And from a desirable point of view for the surgeon, something that's very surgeon friendly, ability to cut it anywhere, he wants to have a long shelf life, etc. So that we ended up with an image on the right hand side there, which shows those two purple vessel that you see as vein grass, we replace them with an artificial graph that we have developed, okay, even the artery graph the, we call the the Lima, going from the top all the way down to the bottom, we can eliminate the need for harvesting that vessel by using one of our graphs as well. Now, a graph, what about it? Well, this is synthetic polymer, in which we build a scaffolding out of this material. Okay, and then we strengthen it with a nitinol support system that will then allow the original synthetic polymers to disappear, go away, go home, okay. And then repeat replace by your own endothelial cells, that is to say that the endothelial cells of that patient, in doing so, we end up with a graph that is very unique to the patient with his or her own cells. And, more importantly, when it disappears. Where do the endothelial cells hang about? Well, they hang on to the nitinol structure that we put around. So as a result, the the artery that we finally end up with, is stronger, more durable than any vessel in your body. What is very interesting, though, we're not at this time doing much work on it, is that this structure can be used, basically, in any part of your body, not just the coronary area. Now, how's it work? Well, we started our animal studies back in 2017, we first started with, with pigs, but we went on to the old line that is the sheep because we were doing studies that were longer and longer and time and the pig just outgrows the table. All right, they get quite big. So we ended up doing sheep, we typically scan these animals for 30, 60, 90 days, because by 90 days, you're pretty well set to go into humans. Okay. We began using the latest materials and planning these things. And now we have graphs that we have machine and created. There are now approaching 120 days, a typical go ahead milestone that we typically do. In fact, we now have animals in excess of 180 days. I think recently, we crossed the 200 day timeline. Now here is what we can do. The way we're doing this, you may ask the question, many why are we showing the same graph three different times correction. This is three different animals, three different implants and yet they look identical. That's what we've been able to do is create graphs that are virtually identical. This is a nice thing for the doctor and a little entity down in Maryland call the FDA. They like to see repeatability. And we're able to show this we now have sheep over 180 days. And if I hit this button again, will this thing run? There we go. Okay, there we are a sheet that is over 180 days now we've been able to bring in some very, very, very top as far high as you can go in our experience of both med tech and business advisors. In the lower left hand corner, we have Dr. Lyle Joyce, who was the previous chief of cardiac surgery for the Mayo Clinic. You may have heard of that place. It's over in the mid part of the country in Minnesota, okay. And and his son joined them as well. Does the heart transplants. Then they both went to Wisconsin to develop a new heart center there or while they're advising us. Okay. We have Bob Emery who helped me develop the St. Jude heart valve. He's a retired surgeon. And we have Dr. Jean Myers, who has done over 20 or 30,000, coronary and peripheral angioplasties. We know the heart very well. Earlier today, you may have heard John Babbitt, a partner of Ernst and Young talking about m&a. He has worked for me in the past. Okay. And I said to John John, okay, you can stay at Ernst and Young, you can do anything you want to do. But if I ever get hit by a truck, guess what? You have to take over and help my guys. So we got everything covered. On the right hand side, you see Dr. Rockavant, one of the original developers of the material that we're using, the techniques that we're using at the University of Iowa, where we got the original licensing from another partner, maybe you've heard of this guy, again, they're located in the Midwest, part of the country, the Mayo Clinic, the Mayo Clinic approached us saying we want to collaborate with you, because this is a very important project, we will help you with your animal work. We want to be participants in your clinical trials. And by the way, do you need any money I said, there's a bear live in the woods, of course, I need money. And so they they kicked in some money as well. I don't know how much time I use. But if we have any time for questions, I'd be more than happy. I must say one thing. Okay. Let me see if I can go a little bit further. Put the Hulk away. Were you for a second. Okay. All right. I have to read this thing to you not read the whole thing. But we are doing. We're approaching the idea of doing our next financing as a reggae and I have to show this slide. Otherwise I get in trouble. Okay. But thank you very much for your attention. I'm gonna put me in a room over here. If you want to talk to me. It'd be fun. Okay, thank you.






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